Responses to Regulated E-Cigarette Advertisements

Not Applicable

Completed

• Conditions: Tobacco Use

• Registration Number: NCT05207033
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest.

Detailed Description

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the proposed study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs, and determine if the restriction of these ad features influences EC attitudes, experimentation, and sustained use. The investigators will experimentally estimate the causal effect of restricting high impact EC ad features on tobacco use behavior. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest. We will also examine how sensation seeking, impulsivity, and sleep health impact EC use. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults, and if restrictions reduce the use of ECs among young adults.

Study Timeline

• Study First Submitted: 2021-12-15
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-26
• Study Start: 2022-04-01
• Primary Completion: 2024-06-04
• Study Completion: 2024-07-01
• Results First Submitted: 2025-04-03
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Results First Posted: 2025-05-30
• Last Update Posted: 2025-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

• 18 to 26 years old,
• fluent in English (earn a score of at least 4 on the Rapid Estimate of Adult Literacy in Medicine)
• biochemically confirmed abstinence of alcohol (BrAC=.00) and combusted tobacco or marijuana exhaled carbon monoxide (eCO<6 parts per million) at time of visit,
• reporting never trying an e-cigarette, not even a puff OR reporting tried and e-cigarette in the past but not in the past 30 days. Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire, with only those identifying anything besides "no curiosity/interest" to all three susceptibility questions as susceptible users.

Exclusion Criteria

• Out of age range 18-26 years
• Use of an e-cigarette in past 30 days
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Tobacco Use at 1 Month	1 month	Use of any tobacco products
Tobacco Use at 3 Months	3 months	Use of any tobacco products
Tobacco Use at 6 Months	6 months	Use of any tobacco products
Perceived Severity of Using E-Cigarettes at 1 Month	1 month	Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree).; I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant.; To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Perceived Severity of Using E-Cigarettes at 3 Months	3 months	Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree).; I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant.; To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Perceived Severity of Using E-Cigarettes at 6 Months	6 months	Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree).; I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant.; To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Number of Participants With Biochemical Verification of Tobacco Use at 3 Months	3 months	Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Motivation to Avoid E-Cigarettes at 1 Month	1 Month	Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very; How important is it to avoid e-cigarettes in the future?; How confident are you in avoiding e-cigarettes in the future?; How ready are you to avoid e-cigarettes in the future?; How committed are you to avoid e-cigarettes in the future?; To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Motivation to Avoid E-Cigarettes at 3 Months	3 Months	Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very; How important is it to avoid e-cigarettes in the future?; How confident are you in avoiding e-cigarettes in the future?; How ready are you to avoid e-cigarettes in the future?; How committed are you to avoid e-cigarettes in the future?; To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Motivation to Avoid E-Cigarettes at 6 Months	6 Months	Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very; How important is it to avoid e-cigarettes in the future?; How confident are you in avoiding e-cigarettes in the future?; How ready are you to avoid e-cigarettes in the future?; How committed are you to avoid e-cigarettes in the future?; To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Behavioral Intentions at 1 Month	1 month	Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes?; How willing are you to try e-cigarettes?; How willing would you be to purchase an e-cigarette?; How willing would you be to try an e-cigarette if a friend offered you one?; Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Behavioral Intentions at 3 Months	3 months	Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes?; How willing are you to try e-cigarettes?; How willing would you be to purchase an e-cigarette?; How willing would you be to try an e-cigarette if a friend offered you one?; Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Behavioral Intentions at 6 Months	6 months	Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes?; How willing are you to try e-cigarettes?; How willing would you be to purchase an e-cigarette?; How willing would you be to try an e-cigarette if a friend offered you one?; Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Number of Participants With Biochemical Verification of Tobacco Use at 1 Month	1 month	Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Number of Participants With Biochemical Verification of Tobacco Use at 6 Months	6 months	Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Trial Locations

Locations (1)

UMass Chan Medical School Stevens Lab; 🇺🇸 Worcester, Massachusetts, United States